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The Difference: Bruesewitz v Berkovitz by F. Edward Yazbak, MD, FAAP

The Difference
Bruesewitz v Berkovitz

22 years
Different Decisions
Different US Supreme
Courts
Different Press and
Public Opinions

The United States Supreme Court recent
decision in Bruesewitz V. Wyeth did not only affect a family. It
affected thousands, who after unsuccessfully pursuing a claim through
the National Vaccine Injury Compensation Program, will no longer be
able to hold a vaccine manufacturer accountable for injuries believed
to be due to an FDA-approved vaccine. By its majority decision, the
court indicated that such secondary lawsuits would be countering the
intent of the National Childhood Vaccine Injury Act of 1986 and risking
the proliferation of tort-based cases the Act was created to prevent.

On the same day, the New York Times published a Pfizer Inc press
release titled “U.S. Supreme Court Decision In Bruesewitz V. Wyeth A
Win For Public Health” under “Business Day Markets”:

WASHINGTON--(BUSINESS WIRE)--Feb. 22,
2011-- Today, in a 6-2
decision, the U.S. Supreme Court affirmed the ruling of the U.S.
Court of Appeals for the Third Circuit in favor of Pfizer’s
subsidiary Wyeth, in Bruesewitz v. Wyeth. The Third Circuit
determined that the National Childhood Vaccine Injury Act prevents
civil suits against manufacturers of FDA-approved childhood vaccines
based on a claim that a particular vaccine should have been designed
differently.

“Vaccines are one of modern medicine's greatest success
stories,” said Pfizer Executive Vice President and General Counsel
Amy Schulman. “Their nearly universal administration to children is
responsible for the elimination of polio and smallpox in the United
States, and the near-elimination and containment of other childhood
diseases. The Vaccine Act that Congress enacted nearly 25 years ago
appropriately places the responsibility for determining the optimal
design of life-saving childhood vaccines in the hands of expert
federal agencies, not a patchwork of state tort systems. We are
pleased that the U.S. Supreme Court affirmed the ruling of the Third
Circuit.”

The
document ended with a commercial for Pfizer:

Pfizer Inc.: Working together for a
healthier world™

At Pfizer, we apply science and our global resources to improve
health and well-being at every stage of life. We strive to set the
standard for quality, safety and value in the discovery, development
and manufacturing of medicines for people and animals. Our
diversified global health care portfolio includes human and animal
biologic and small molecule medicines and vaccines, as well as
nutritional products and many of the world’s best-known consumer
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time. Consistent
with our responsibility as the world’s leading biopharmaceutical
company, we also collaborate with health care providers, governments
and local communities to support and expand access to reliable,
affordable health care around the world. For more than 150 years,
Pfizer has worked to make a difference for all who rely on us. To
learn more about our commitments, please visit us at www.pfizer.com

The press release was provided by Pfizer Inc to many other newspapers
and outlets including the Wall Street Journal.
[http://tinyurl.com/4hdqgnh]

Many have discussed the Bruesewitz case and by now, those interested in
the subject are well aware of the decision and of the fact that
Justices Ruth Bader Ginsburg and Sonia Sotomayor dissented.

Two quotes from that black day are worth remembering: One by Justice
Sotomayor: “Nothing in the 1986 law remotely suggests that Congress
intended such a result" and the other by Attorney David Frederick, the
Bruesewitz family attorney: "I'm disappointed for the families of
victims of defectively designed vaccines, who now have no remedy at law
for their injuries."

~~~~~~

Things
were certainly different in 1988, when the United States Supreme
Court decided Berkovitz v. United States.

First
the “Media Reaction” then the case and the decision:

On
Tuesday June 14, 1988, the Washington Post carried the first report
about the decision:

“Court
rules Government Liable for Negligence”.

The detailed article included the following remarkable quote by
Justice Thurgood Marshall: “We intend specifically to reject the
government’s argument that a provision of the Federal Torts Claims
Act shields the government for liability for any and all acts arising
out of the regulatory problems of federal agencies.”

On
the same day, the New York Times reported the decision and its
details in its Supreme Court Roundup under the title:

“Court
Eases Way to Sue U.S. For Safety
Policy Violations”

On
Friday June 17, the Washington Post published the following opinion:

One perennial nightmare of all parents
is
the possibility that a defective vaccine might injure a child. The
drug companies have always been liable for damages in those cases. But
these vaccines are produced under stringent federal regulation,
and now the Supreme Court says the government can be sued if it fails
to carry out its own safety rules.

No responsible parent would allow a child to
remain unprotected against polio or any of several other deadly
diseases, and this kind of pharmaceutical disaster is rare. But it
happens. The FDA says that there are currently four other polio
vaccine cases pending in lower courts.

In the case that went to the Supreme Court,
an infant two months old had been given a dose of Orimune, an oral
vaccine that resulted in a full-blown case of polio and severe
paralysis. The manufacturer, Lederle Laboratories, settled out of
Court. Then the child’s parents sued the government charging that
the FDA had allowed the vaccine to be distributed in violation of its
own standards. The Government lawyers argued that Congress has
specifically given regulators discretion, and granted them immunity
from lawsuits when they exercise it.

Not so fast, said the Supreme Court. Justice
Marshall, writing for a unanimous court, agreed that Congress has
given administrators discretion to make rules. But once the rules are
set, administrators don’t have the discretion to evade or bend
them. Congress, he said, never intended to protect regulatory
corner-cutting.

The injured child’s parents charge that
some of the FDA’s employees allowed the vaccine to be shipped with
the knowledge that it was not quite up to standard. The court’s
decision now gives the parents an opportunity to prove that
accusation in a trial and, if they succeed, to collect damages from
the Government itself.

This decision reaches far beyond vaccines to
every kind of health, safety and environmental regulation. For all of
the endless talk in the Reagan administration about the revolt
against the regulators, those are three areas in which the principles
laid down in the 1970s remain undiminished. There has been plenty of
deregulation over the years, but it has been elsewhere – in
finance, transportation and communications. The federal laws to
protect your life and your health have not been rolled back.

Now the Supreme Court has created a powerful
sanction to force tighter enforcement of those laws and the
administrative regulations that carry them out. No one who has ever
watched a child be vaccinated will doubt that, in its impact on the
regulators, the effects of this decision can only be healthy.”

I believe I can safely say that we are not likely to ever read again
anything remotely similar to this in any newspaper anytime soon.

***

Berkovitz v. United States, 486 U.S. 531 (1988) was argued in the
United States Supreme Court on April 19, 1988 and decided June 13,
1988.

As mentioned, Justice Thurgood
Marshall, a giant, delivered the unanimous opinion of the
Court. He started: “The question in this case is whether the
discretionary function exception of the Federal Tort Claims Act (FTCA
or Act), 28 U.S.C. 2680(a), bars a suit based on the Government's
licensing of an oral polio vaccine and on its subsequent approval of
the release of a specific lot of that vaccine to the public.”

Justice Marshall went on discussing the details of the case and
what happened in the lower courts summarizing the opinion of the
court relative to the vaccine lots as follows:

“Viewed in light of these
principles, petitioners' claim
regarding the release of the vaccine lot from which Kevan Berkovitz
received his dose survives the Government's motion to dismiss.
Petitioners allege that, under the authority granted by the
regulations, the Bureau of Biologics has adopted a policy of testing
all vaccine lots for compliance with safety standards and preventing
the distribution to the public of any lots that fail to comply.
Petitioners further allege that notwithstanding this policy, which
allegedly leaves no room for implementing officials to exercise
independent policy judgment, employees of the Bureau knowingly
approved the release of a lot that did not comply with safety
standards. See App. 13; Brief for Petitioners
20-21; Reply Brief for Petitioners 15-17. Thus,
petitioners' complaint is directed at a governmental action that
allegedly involved no policy discretion. Petitioners, of course, have
not proved their factual allegations, but they are not required to do
so on a motion to dismiss. If those allegations are correct - that
is, if the Bureau's policy did not allow the official who took the
challenged action to release a noncomplying lot on the basis of
policy considerations - the discretionary function exception does not
bar the claim. 13
Because petitioners may yet show, [486 U.S.
531, 548] on the basis of materials obtained in
discovery or otherwise, that the conduct challenged here did not
involve the permissible exercise of policy discretion, the invocation
of the discretionary function exception to dismiss petitioners' lot
release claim was improper.

IV

For the foregoing reasons, the Court of Appeals erred in holding
that the discretionary function exception required the dismissal of
petitioners' claims respecting the licensing of Orimune and the
release of a particular vaccine lot. The judgment of the Court of
Appeals is accordingly reversed, and the case is remanded for further
proceedings consistent with this opinion.

It is so ordered.

*****

There was indeed a difference between Bruesewitz and Berkovitz.

The Berkovitz decision was right and fair.

The Bruesewitz decision was neither.

By now, many have forgotten Berkovits.

As of now, many more will remember Bruesewitz and the unfortunate
decision that is certain to affect thousands just as it has affected a
devastated deserving and loving family.

"I know of no safe depository of the ultimate powers of the society but the people themselves, and if we think them not enlightened enough to exercise control with a wholesome discretion, the remedy is not to take it from them, but to inform their discretion by education."

-- Thomas Jefferson, letter to William C. Jarvis, September 28, 1820

“A sacred cow will not protect the herd.”

-- Sandy Gottstein

"What's the point of vaccination if it doesn't protect you from the unvaccinated?"

-- Sandy Gottstein

"Who gets to decide what the greater good is and how many will be sacrificed to it?"